Background
The present subanalysis of the Study of Once Daily Levemir (SOLVE) study was to evaluate the safety and efficacy of once‐daily insulin detemir as add‐on to oral antidiabetic drugs (OADs) in Chinese type 2 diabetes patients according to body mass index in a real‐life setting.
Methods
In all, 3272 eligible patients who were treated with diet, exercise, and one or more OAD were prescribed once‐daily insulin detemir by their physician according to routine clinical practice and were followed‐up for 24 weeks. The incidence of serious adverse reactions (SADRs), including major hypoglycemia, was the primary endpoint. Subanalyses were performed on patients in the following BMI groups: normal weight (BMI < 25 kg/m2); overweight (25 ≤ BMI < 30 kg/m2); and obese (BMI ≥ 30 kg/m2).
Results
No SADRs were reported during the study. Significant improvements in glycemic levels were observed in all subgroups. For normal weight, overweight, and obese patients, the mean change in HbA1c (%/[mmol/mol]) was −1.26/−14, −1.09/−12, and −1.06/−12, respectively. The mean change in fasting plasma glucose in normal weight, overweight, and obese patients was −2.77, −2.57, and −2.71 mmol/L, respectively. Slight weight gain (0.25 kg), slight weight loss (–0.36 kg), and weight loss (–1.32 kg) were observed in the normal weight, overweight, and obese patients, respectively (P < 0.001). Linear regression analysis revealed a negative relationship between weight change and baseline BMI (slope = −0.16; P < 0.001).
Conclusions
Once‐daily insulin detemir as add‐on to OADs in Chinese patients with type 2 diabetes showed effective glycemic control and a low risk of hypoglycemia. Weight‐neutral effects were observed in different BMI subgroups.